Antibiotic Safety (SCAMP)

Michael Cohen-Wolkowiez

Status and phase: Completed; Phase 3; Phase 2

Conditions: Complicated Intra Abdominal Infections

Treatments: Drug: standard of care antibiotics and metronidazole; Drug: metronidazole, clindamycin, or piperacillin-tazobactam; Drug: gentamicin and Piperacillin- tazobactam; Drug: ampicillin and gentamicin and clindamycin; Drug: ampicillin and metronidazole and gentamicin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01994993

Pro00048773

HHSN275201000003I (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections

Full description

The most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. This study will provide the safety information required for labeling. In addition, the pharmacokinetics(PK) and effectiveness data will also be collected during this study.

Enrollment: 260 patients

Sex: All

Ages: Under 120 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Informed consent obtained from parent(s) or legal guardian(s) (Groups 1-5)
2. ≤33 weeks gestation at birth (Groups 1-3, 5)
3. ≥34 weeks gestation at birth (Groups 4 and 5)
4. PNA <121 days (Groups 1-5)
5. Sufficient venous access to permit administration of study drug (intravenous [IV]) (Groups 1-5)
6. Presenting physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection within 48 hours prior to randomization/first study drug dose (Groups 1-4)**. Complicated intra-abdominal infections include secondary peritonitis, NEC grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous intestinal perforation, meconium ileus with perforation, bowel obstruction with perforation, gastroschisis with necrosis and/or perforation, omphalocele with necrosis and/or perforation, neonatal appendicitis, intestinal pneumatosis or portal venous gas, free peritoneal air on abdominal radiographic examination, or abdominal abscess.
7. Suspected or confirmed infection for which the study drug may provide therapeutic benefit and planned CSF collection per standard of care (Group 5).

Exclusion Criteria*

1. History of anaphylaxis in response to study drugs (Groups 1-5)

2. Serum creatinine >2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)**

3. Known ALT >250 U/L or AST >500 U/L on measurement closest to the time of randomization or first study drug dose (Groups 1-5)**

4. Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (Groups 1-5)

   • Do not apply for Group 5 participants receiving drug per standard of care

     • Criteria must be satisfied by randomization (randomized Groups 1-3) or first study drug dose (non-randomized Groups 1-3, Group 4 and Group 5), whichever comes first.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 5 patient groups

Group 1 (ampicillin +gentamycin +metronidazole)

Active Comparator group

Description:

Ampicillin and gentamycin and metronidazole

Treatment:

Drug: ampicillin and metronidazole and gentamicin

Group 2 (ampicillin +gentamicin+clindamycin)

Active Comparator group

Description:

ampicillin and gentamicin and clindamycin

Treatment:

Drug: ampicillin and gentamicin and clindamycin

Group 3 (piperacillin-tazobactam and gentamicin)

Active Comparator group

Description:

piperacillin-tazobactam and gentamicin

Treatment:

Drug: gentamicin and Piperacillin- tazobactam

Group 4 (metronidazole)

Active Comparator group

Description:

Per standard of care antibiotics, and Metronidazole

Treatment:

Drug: standard of care antibiotics and metronidazole

Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)

Active Comparator group

Description:

metronidazole, clindamycin, or piperacillin-tazobactam

Treatment:

Drug: metronidazole, clindamycin, or piperacillin-tazobactam